Influence of the Use of Specific Nutritional Formulas on Time in Range in Patients With Type 2 Diabetes

June 18, 2026 updated by: Hospital Universitario San Ignacio

Influence of the Use of Specific Nutritional Formulas for Diabetes on Time in Range in Patients With Type 2 Diabetes Mellitus With Obesity by Freestyle Continuous Glucose Monitoring

Who can participate?

Individuals may be eligible to join this study if they meet the following criteria:

  • Are 18 years or older.
  • Have Type 2 diabetes with an A1c level higher than 7%.
  • Have a Body Mass Index (BMI) between 27 and 35 (considered overweight or Class 1 obesity).
  • Have used a continuous glucose monitor (CGM) successfully in the past.

How the study works:

If eligible individuals decide to join and sign the consent form, a computer will randomly assign them into one of two groups:

The Formula Group: Participants will replace their usual breakfast and one snack with a specific diabetes nutritional drink (Glucerna®).

The Standard Diet Group: Participants will follow a standard low-calorie meal plan without using the nutritional drink.

Both groups will aim for a specific daily calorie goal (1,200-1,500 for women; 1,500-1,800 for men) and will receive expert nutritional counseling.

Monitoring and Follow-up

Over the course of 3 months, close contact will be maintained to support participants:

Every 2 weeks: A nutrition expert will call participants to check on their diet and help with their glucose monitor.

Every month: Participants will meet with the study team in person to review glucose monitor data.

Tests: At the start and end of the study, weight, body composition, blood sugar (A1c), and cholesterol levels will be measured to see how the plans worked.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled clinical trial will be conducted with two parallel groups, which will include patients over 18 years of age with type 2 DM, HbA1c > 7%, and grade 1 obesity (BMI >27 kg/m2 and <35 kg/m2), who have previously used continuous glucose monitoring (CGM) with adherence greater than 70%, and who are able to follow the study protocol.

After signing the informed consent, REDcap® will be used to computer-generate the random sequence for group assignment; the intervention group will use a specific nutritional formula for diabetes (FNED) (Glucerna®) (Appendix 1) as a replacement for breakfast and snack to achieve targets of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men, and the control group will continue to be prescribed a low-calorie diet of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men without the use of FNED for a period of 3 months. Both groups will receive nutritional counseling according to the diabetes support and self-care education plan.

CGM, body composition, and baseline paraclinical variables will be collected, and every 14 days, adherence to dietary treatment will be verified by telephone using a 24-hour multi-step reminder with advice from a dietary team, and correct use of the device will be verified. CGM records are reviewed in person monthly using the LibreView" platform. CGM data, body composition and HbA1c, total cholesterol, HDL, LDL, baseline triglycerides will be analyzed at 3 months of follow-up.

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Diana C Henao-Carrillo, Endocrinologyst
  • Phone Number: 2817 +57 601 5946161
  • Email: dchenao@husi.org.co

Study Contact Backup

  • Name: Ana M Gómez - Medina, Endocrinologyst
  • Phone Number: 2817 +57 601 5946161
  • Email: agomez@husi.org.co

Study Locations

  • Colombia
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 111021
        • Hospital Universitario San Ignacio
        • Contact:
          • Diana C Henao-Carrillo, Endocrinologyst
          • Phone Number: 2817 +57 601 5946161
          • Email: dchenao@husi.org.co
        • Contact:
          • Ana M Gómez Medina, Endocrinologyst
          • Phone Number: 2817 +57 601 5946161
          • Email: agomez@husi.org.co

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Patients over 18 years of age.
  • Diagnosis of diabetes mellitus type 2.
  • HbA1c >7% to <11%.
  • BMI >27 kg/mt2 <35 kg/mt2
  • Current use of continuous glucose monitoring with adherence greater than 70%.
  • Access to technology to download data from CGM in a timely manner.
  • Ability to follow the study protocol and provide informed consent (Appendix 3).

Exclusion criteria:

  • Change in antidiabetic medication in the last 3 months.
  • Pregnancy or lactation or planning to become pregnant during the study period.
  • Acute decompensation of diabetes in the past 3 months.
  • Participation in another clinical trial.
  • Use of glucocorticoids or insulin in the past 3 months or planned use in the coming months.
  • Initiation of treatment with oral or injectable GLP-1 analogues 3 months prior to enrollment.
  • History of bariatric surgery or gastrointestinal pathology associated with malabsorption syndromes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glucerna
A calorie-restricted diet plan is prescribed (see Table 1). In this group, Glucerna will be prescribed for breakfast and snacks as part of the total calories calculated for each patient's meal plan.
Dietary supplement: Glucerna
A calorie-restricted diet plan is prescribed (see Table 1). In this group, Glucerna will be prescribed for breakfast and snacks as part of the total calories calculated for each patient's meal plan. Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
Other: Caloric restriction
Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
Placebo Comparator: Placebo
Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
Other: Caloric restriction
Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range
Time Frame: 3 months
Time in range 70 - 180 mg/dl
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 3 months
HbA1c
3 months
Weight
Time Frame: 3 months
Weight in kilograms
3 months
body composition
Time Frame: 3 months
fat mass, musculoskeletal mass, visceral fat mass
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario San Ignacio

Collaborators

Abbott Nutrition

Investigators

  • Principal Investigator: Ana M Gómez-Medina, Endocrinologyst, Hospital Universitario San Ignacio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FM-CIE-0840-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated during and/or analyzed during the current study are not publicly available due contains clinical data of patients being monitored at the Hospital Universitario San Ignacio but are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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